Kornimate/medical-research-clean huggingface dataset:
fluid responsiveness prediction using extra systoles

Conditions: Fluid Responsiveness

Summary: fluids are generally administered to patients in order to improve circulation. however, fluids do not always improve circulation and fluids have side effects. unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness the overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: the second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. as such, the post ectopic beat shows how the heart responds to increased filling. therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness


Eligibility criteria:
inclusion criteria: * patients scheduled for a 500 ml volume expansion * patients without atrial fibrillation * patients equipped with ecg, arterial pressure and non-invasive cardiac output monitoring exclusion criteria: * changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion). * changes in positive end-expiratory pressure the study period * changes in bed positioning the study period * infusion time with crystalloids exceeding 30 minutes * infusion time with colloids exceeding 75 minutes

Keywords: fluid responsiveness volume responsiveness hemodynamics
pain and anxiety management with oral narcotic for pediatric suture repair

Conditions: Children; Lacerations; Procedures; Child; Pain

Summary: the purpose of this study is: * to determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment * to evaluate for a statistical difference in pain scores in children during laceration repair * to evaluate for a statistical difference in state-trait anxiety inventory for children (staic) scores during laceration repair

a prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. allocation concealment will be ensured by opaque, sealed envelopes kept in the emergency department pharmacy. guardians of patients age 2 to 17 years of age will be consented for enrollment.

Eligibility criteria:
inclusion criteria: * age 2 to 17 years * laceration of the skin and/or subcutaneous tissue requiring sutures * american society of anesthesiologists (asa) score of i or ii exclusion criteria: * major injuries in addition to laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury) * abnormal neurologic examination (such as head injury) * severe congenital heart disease * pregnancy * known opiate or acetaminophen allergy * require conscious sedation * have had narcotic or acetaminophen administration within 4 previous hours

Keywords: lacerations sutures pediatrics child pain anxiety
assess efficacy, immune response & safety of 2 doses of oral live attenuated hrv vaccine in healthy infants

Conditions: Infections, Rotavirus

Summary: to assess the efficacy, immune response and safety of the oral live attenuated hrv vaccine (rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus


Eligibility criteria:
inclusion criteria: * healthy infants 6 and 12 weeks of age at the time of the first vaccination. * written informed consent obtained from the parents or guardians of the subject. * born after a normal gestation period (between 36 and 42 weeks). exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. (topical steroids are allowed.) * use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after. * any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). * household contact with an immunosuppressed individual or pregnant woman. * abnormal stool pattern. * administration of immunoglobulins and/or blood products since birth or planned administration during the study period. * previous confirmed occurrence of rotavirus gastroenteritis.

Keywords: oral live attenuated human rotavirus vaccine gastroenteritis
sepsis: prognosis and evaluation of early diagnosis and intervention (speedi study)

Conditions: SIRS; Sepsis

Summary: background: in november 2003 the medical director at copenhagen university hospital, hvidovre, gathered a group of doctors involved in the diagnosis and treatment of patients with sepsis. amis: to develop a fast and reliable tool that can guide the physician in the diagnosis and treatment of the septic patient thereby reducing mortality and morbidity. the measurement of markers of inflammation, coagulation, infection and specific bacterial antigens in the same plasma sample will give insight to the pathogenesis of sepsis and sirs and the bodies responds to the disease. material and methodes: case-control study nested in cohort. 300 patients admitted to the hospital from 1.01.05 to 01.07.06. copenhagen university hospital, hvidovre, an 800 beds hospital, covers a part of copenhagen with a wide variety in the population's socioeconomic and cultural background. for the analysis of markers the luminex 100 lab analysis system is used. it utilizes xmap® technology which enables you to simultaneously assay up to 100 analytes in a single well of a microtiter plate, using very small sample volumes. assay development of a 15-plex is don in-house. coworkers \& founding: the following departments at the hospital, are coworkers in the speedi study: clinical research unit, departments of infectious disease, clinical microbiology, clinical biochemistry, gastroenterology (incl. surgery), intensive care unit, emergency room, and the hospital board of directors. all departments have research experience and a long tradition of publication of scientific works. the study received founding for equipment and salaries during the first phase of the study from the hospitals board of directors. applications to major public foundations in denmark are awaiting answer. no commercial interest are involved in the study. future applications: a second phase of the study including children admitted at the hospital is in preparation. the very small sample volume is a great advantage in diagnosing infection in children. the applications of the study results will hopefully provide the physician with the needed tool for a fast and reliable diagnosis, prognosis and treatment guide for the patients suffering from sirs and sepsis.


Eligibility criteria:
inclusion criteria: * patients admitted with ≧ 2 of the following 4 symptoms of sirs: * resp. rate \> 20/min * heart rate \> 90/min * temperature \> 38ºc or \<36ºc * leukocytes \>12.000 or \<4.000 exclusion criteria: * admitted to a hopital \>24 h prior to inclusion * antibiotic therapy initiated at a hospital \>8 h prior to inclusion

Keywords: sepsis sirs biomarkers xmap
a clinical study comparing superior capsule reconstruction using different graft for irreparable rotator cuff tear

Conditions: Rotator Cuff Tears

Summary: biomechanical and clinical success of the superior capsule reconstruction (scr) using fascia lata (fl) grafts has been reported in treating irreparable rotator cuff tear. human dermal (hd) allograft has been used successfully for scrs; however, the clinical comparative study between fl and hd have not been reported.


Eligibility criteria:
inclusion criteria: * patients with irreparable rotator cuff tears * underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft * at least two years follow-up exclusion criteria: * reparable rotator cuff tears * underwent partial repair or reverse total shoulder arthroplasty

Keywords: irreparable rotator cuff tears superior capsular reconstruction fascia lata allograft human dermal allograft
study assessing the safety, tolerability, pharmacokinetics, and immunogenicity of repeated subcutaneous doses of anti-spike (s) sars-cov-2 monoclonal antibodies (regn10933+regn10987) in adult volunteers as related to covid-19

Conditions: Healthy; Chronic Stable Illness

Summary: the primary objectives are: * to assess the occurrence of adverse events of special interest (aesis) in participants treated with repeated subcutaneous (sc) doses of regn10933+regn10987 compared to placebo * to assess the concentrations of regn10933 and regn10987 in serum over time after single and repeated sc administration the secondary objectives are: * to assess the safety and tolerability of repeated sc doses of regn10933+regn10987 compared to placebo * to assess attainment of target concentrations of regn10933 and regn10987 in serum after single and repeated sc administration * to assess the immunogenicity of regn10933 and regn10987


Eligibility criteria:
key inclusion criteria: 1. is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study 2. stable medication for co-morbid condition(s) for at least 6 months prior to screening 3. willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to sars-cov-2 infection and transmission key exclusion criteria: 1. positive diagnostic test for sars-cov-2 infection ≤72 hours prior to randomization 2. subject-reported clinical history of covid-19 as determined by investigator 3. subject-reported history of prior positive diagnostic test for sars-cov-2 infection 4. active respiratory or non-respiratory symptoms suggestive or consistent with covid-19 5. medically attended acute illness, systemic antibiotics use, or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening 6. acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[copd\], asthma exacerbations) in the past 6 months prior to screening 7. received investigational or approved sars-cov-2 vaccine 8. received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis as defined in the protocol 9. use of remdesivir, intravenous immunoglobulin (ivig), or other anti-sars viral agents within 2 months prior to screening note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2)
study of the changes in metabolic parameters in patients treated with escitalopram for six months

Conditions: Major Depression; Generalized Anxiety Disorder; Panic Disorder

Summary: the purpose of this study is to explore the changes in metabolic parameters in patients treated with escitalopram for six months for major depression, generalized anxiety disorder or panic disorder, with or without agoraphobia.

this is an open-label study, with 4 scheduled visits. recruitment of 100 subjects. assessments include demographics, diagnosis, smoking frequency, clinical global scale (cgi-s), weight, height,blood pressure, waist and hip circumference and fasting blood glucose and lipd profile. statistical analysis will be exploratory and mainly descriptive.

Eligibility criteria:
inclusion criteria: * give informed consent * requires pharmacological treatment with escitalopram for major depression, generalized anxiety disorder or panic disorder * aged 21 years old and above * able to comprehend and comply with protocol * not pregnant and if of child-bearing age, using adequate methods of contraception exclusion criteria: * currently taking or has taken in previous 3 months, any other antidepressants, antipsychotics, mood stabilizers, weight loss or lipid-profile modifying drugs * contraindications to escitalopram * unstable medical illness and/or is already under treatment of diabetes, hypertension, dyslipidemia, ischemic heart disease * history of non-response to escitalopram * meets idf definition of metabolic syndrome * significant risk of suicide * primary diagnosis or comorbid diagnosis of psychotic disorder, bipolar disorder, substance dependence and/or dementia

Keywords: metabolic parameters escitalopram metabolic syndrome antidepressant
trial of a nurse led hypertension clinic in inner city general practices

Conditions: Hypertension

Summary: the investigators will do a trial in two general practices to see if the introduction of a blood pressure clinic staffed by a specialist nurse supported by visiting consultant improves blood pressure control compared to usual care.


Eligibility criteria:
inclusion criteria: * patients with last recorded blood pressure greater or equal to the british hypertension society audit standard exclusion criteria: * secondary hypertension * housebound * non-english speaking * another major illness likely to dominate pattern of care e.g. advanced cancer, dementia

Keywords: hypertension, clinical trial, nurse-led clinic, primary care
anlotinib plus pemetrexed or pemetrexed for previously untreated elderly (>=70) or ps=2 non-squamous nsclc

Conditions: Advanced Non-squamous NSCLC

Summary: evaluate the efficacy and safety of anlotinib plus pemetrexed as the 1-line treatment of patients with platinum intolerant advanced non-squamous nsclc, with pemetrexed control.

anlotinib (al3818) is a kind of innovative medicines approved by state food and drug administration（sfda:2011l00661） which was researched by jiangsu chia-tai tianqing pharmaceutical co., ltd. anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for vegfr1、vegfr2、vegfr3、fgfr1/2/3、pdgfra/β c-kit and met.

Eligibility criteria:
inclusion criteria: * ≥70 years old and ecog ps=0-2 or ≥18 years old and ecog ps=2 * diagnosed with advanced or recurrent non-squamous nsclc (phase iiib/iv) through pathology, with measurable nidus(using recist 1.1) * no prior systemic treatment for non-squamous nsclc * negative in egfr\&alk\&ros1 * main organs function is normal exclusion criteria: * have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding * symptoms of brain metastases cannot be controlled and treated within less than 21 days * have participated in other clinical trials of anti-tumor medicine within 4 weeks * get any severe diseases or the ones that cannot be controlled
combined rg3-enriched korean red ginseng and american ginseng in the management of hypertension in type 2 diabetes

Conditions: Diabetes Mellitus Type 2; Hypertension

Summary: the study is a combined phase-i like (safety) and phase-ii like (efficacy) double blind randomized placebo controlled trial. the objective is to investigate whether the combination of ag and rg3-enriched korean red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: hba1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.


Eligibility criteria:
inclusion criteria: * between the age of 40 and 75 years * type 2 diabetes (at least 1 year duration, hba1c ≥ 6.5%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications) * clinically diagnosed and treated hypertension according to canadian diabetes association clinical practice guidelines * normal thyroid, kidney and liver functions * female subjects recruited for the study must be post-menopausal or had absence of menstruation for ≥ 1 year or is taking contraceptive precautions exclusion criteria: * insulin therapy * history of angina, myocardial infarction or stroke * systolic blood pressure \>160 mmhg and/or diastolic blood pressure \>100 mmhg * use of ginseng within 1 month start of study * bmi \>35 kg/m2 * smoking cigarettes * alcohol intake of \> 2 drinks/day * recently given blood * have an upcoming planned surgery * gfr \<60 ml/min/1.73m2 * prolonged qt (\>20 ms) interval as assessed by ecg * changes to use of natural health products that may effect blood pressure and/or diabetes * weight change more than +/- 3 kg/month * hiv infection, inflammatory bowel disease, celiac disease, heart disease, bleeding disorder, sleep disorder, arrhythmia * pregnant or breastfeeding * use of anticoagulant (excluding aspirin), antiplatelet, sedative, sympathomimetic, photosensitizing or anti-depressant drugs * hormone replacement therapy, furosemide, morphine, glucocorticoids * presence of any conditions which, in the opinion of the qualified investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results * known sensitivity or allergy to any test product or placebo ingredients
efficacy and safety study of evera to augment small breast

Conditions: Atrophy of Breast

Summary: expected total number of subjects * level of significance, alfa 0.05 * power 0.80 * mean difference between two treatments is assumed 35 * standard deviation is assumed 35. * follow-up loss is assumed 20% * n=34(each group:17)

study design * single center, randomized, unblind clinical study medical device * investigational medical device: evera * comparator: estes process * for eligible subjects, investigator apply standard deviation or comparator on the breast * the investigational medical device is determined by randomization. * subjects will be applied for 12 weeks. * subjects will receive patient compliance diary * subjects will visit the hospital to measure breast volume with vivid 9i every 2 weeks for 16weeks

Eligibility criteria:
inclusion criteria: * female aged between 24 and 40 * bmi of over 20 * subjects who want to augment breasts * subjects who understand the study contents and signed the informed consent * subjects who can follow study procedure exclusion criteria: * pregnant or lactating subjects

Keywords: small breast augmentation breast volume external soft tissue expansion system(estes)
a trial of an augmented exercise program in the prevention of deconditioning among survivors of severe burns

Conditions: Deconditioning Among Survivors of Severe Burns

Summary: burn injuries can affect how well you are able to perform daily activities. the reason this study is being done is to find out if aerobic exercise helps burn patients recover function, strength and stamina. participants will come to johns hopkins bayview medical center, burn rehabilitation gym for treadmill exercise sessions 3 days per week for 12 weeks. participants will be tested for strength and stamina before the start of the 12 week program, at the end of the 12 week program, as well as 6 months, 1 year and 2 years after the end of the 12 week program. patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate.


Eligibility criteria:
inclusion criteria: * patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate exclusion criteria: * history of heart-related health problems * foot burns

Keywords: burn injuries exercise
thread embedding acupuncture for rhinitis allergy

Conditions: Rhinitis Allergic

Summary: rhinitis allergy is chronic non-communicable disease with a rapid increase in the number of patients since 1990s. rhinitis allergy is one of the risk factors for various chronic others including asthma, sinusitis, otitis media, as well as some conditions sleep disorders, emotional disorders related. there are numerous pharmacological and non-pharmacological therapies that have been employed in management of these condition. among them, thread embedding acupuncture (tea) has been a widely used and established method for various chronic diseases, demonstrating its effectiveness, safety, and convenience. several studies have shown a significant increase in treatment when combining tea with pharmacological or other acupuncture therapies. however, there is currently no substantial data on the application of tea for rhinitis allergy treatment. this study is conducted to assess the efficacy and safety of combining tea with inhaled corticosteroid (incs) compared with ics monotherapy in rhinitis allergy

eligible participants with rhinitis allergy, defined according to the criteria set by allergic rhinitis and its impact on asthma (aria) 2008, will be enrolled and subsequently randomized into two groups: the intervention group (tea + incs group) and the control group (incs), with a 1:1 allocation ratio. in both groups, the intervention duration is four weeks, with inhaled corticosteroid (incs) - fluticasone propionate used for four weeks in required and life style changing. for the intervention group, thread embedding acupuncture (tea) therapy will be added every two weeks, totaling two sessions during the four-week period. data regarding number of symptoms, bmi, visual analogue scale (vas), rhinoconjunctivitis quality of life questionnaire (rqlq), relief medication score and adverse effects will be recorded immediately following randomization and weekly thereafter over the eight-week duration.

Eligibility criteria:
inclusion criteria: * those not participating in any other clinical trial * those who provide written informed consent * those with typical symptoms of ar, rhinorrhea, sneezing, nasal obstruction, and pruritus. these symptoms should last at least one hour most day since last two week. exclusion criteria: * pregnancy, lactation, or recent childbirth within the past 6 months. * those were receiving immune therapy * those with other allergic diseases such as bronchial asthma or allergic purpura * those with nasal polyposis * those with heterologous protein allergy * those with other disorders such as aids, vascular malformation, hypertension, hematologic, diseases, diabetes mellitus, malignant tumor, or mental disorders.

Keywords: rhinitis allergic thread embedding acupuncture traditional medicine